ERYTECH Provides Business Update and Reports Financial Results for Full Year 2017
Conference call and webcast on
- Reported positive data from Phase 2b clinical trial of eryaspase in second-line metastatic pancreatic cancer
- Resubmitted the European Marketing Authorization Application (MAA) for eryaspase (GRASPA®) in relapsed and refractory acute lymphoblastic leukemia (ALL)
- Raised approximately €194 million (
$226 million ) in capital through a private placement inApril 2017 and a global public offering in connection with Nasdaq listing inNovember 2017 - Cash position of €185.5 million (
$223 million ) at year-end
“2017 was a transformative year for ERYTECH with the achievement of a
number of important clinical, regulatory and financial objectives,” said
Full Year and Recent Business Highlights
-
In
September 2017 , ERYTECH reported the full data set from its open-label, multi-center, randomized Phase 2b trial evaluating eryaspase in combination with chemotherapy for the treatment of second-line metastatic pancreatic cancer. In the trial, patients treated with eryaspase achieved significant improvement in both overall survival (OS) and progression-free survival (PFS). -
The company is now preparing for the launch of a pivotal Phase 3
clinical trial in this same indication in
the United States andEurope . Feedback on the design of the trial was obtained from theU.S. Food and Drug Administration (FDA ) and theCommission for Human Medicinal Products (CHMP) of theEuropean Medicines Agency (EMA). The proposed Phase 3 trial will evaluate eryaspase in combination with standard chemotherapy, compared to standard chemotherapy alone, in approximately 500 patients inthe United States andEurope . The primary endpoint will be overall survival (OS). Enrollment of the first patient in this trial is expected in the third quarter of 2018. - ERYTECH is also broadening the scope of eryaspase to first-line pancreatic cancer, as well as to other solid tumor indications. Recently, the company announced the selection of triple negative breast cancer (TNBC) as the next target indication for expanding the potential treatment scope of eryaspase. ERYTECH is preparing a Phase 2 proof-of-concept clinical trial for this indication and expects to enroll the first patient in this trial in the third quarter of 2018.
-
In
October 2017 , ERYTECH resubmitted its MAA for eryaspase (GRASPA) for the treatment of relapsed and refractory (R/R) ALL. The MAA resubmission includes the Phase 2/3 clinical trial data from children and adults with R/R ALL as well as additional data to address the outstanding questions of the CHMP. CHMP feedback is expected by the end of 2018. -
In
October 2017 , the company also identified the recommended dosing from its open-label, dose escalation Phase 1 clinical trial evaluating the safety of eryaspase in combination with chemotherapy for first-line treatment of adult ALL patients, conducted at five clinical sites acrossthe United States . The steering committee reviewed the safety data of the three treatment cohorts and approved further development at a dose level of 100 U/kg. Based on these data and the clinical results obtained inEurope , the company is preparing to discuss next steps for its development in ALL with theFDA in the second quarter of this year. -
In
December 2017 , the company announced topline results from the Phase 2b clinical trial evaluating eryaspase for the treatment of AML. The open-label, randomized, multi-center clinical trial enrolled a total of 123 patients at 30 European sites. The trial did not meet its primary endpoint of OS. Patient selection is likely the most important factor: the median age of patients in the trial was 78 years, and the median duration of treatment was 5-6 weeks in both treatment arms. -
Throughout 2017, the company also advanced its preclinical pipeline
programs:
-
In spring 2017, the company presented preclinical data on its
erymethionase product candidate at the 2017
American Association for Cancer Research (AACR) Annual Meeting. Based on these preclinical studies, the company believes that erymethionase represents a promising new treatment approach against a broad range of cancers that rely on methionine metabolism. -
In
September 2017 , ERYTECH presented early preclinical data on its eryminase and erymethionase programs at the 13thInternational Congress of Inborn Errors of Metabolism (ICIEM). The findings from the research on eryminase, consisting of arginine deiminase encapsulated in red blood cells, showed a decrease in arginine levels in a disease model of arginase-1 deficiency, supporting a potential treatment approach for hyperargininemia. This study was conducted in collaboration with Queen’s University inCanada . The company's preclinical data involving erymethionase, which is methionine- γ-lyase encapsulated in red blood cells, showed lower homocysteine levels, supporting a potential treatment approach for homocystinuria. This study was conducted through a research collaboration with theFox Chase Cancer Center (FCCC ). - ERYTECH also continues to explore its ERYMMUNE program, in which it intends to use its proprietary ERYCAPS platform to encapsulate tumor antigens within red blood cells as a potentially innovative approach to cancer immunotherapy. Preclinical proof-of-concept studies of ERYMMUNE are ongoing.
-
In spring 2017, the company presented preclinical data on its
erymethionase product candidate at the 2017
Full Year 2017 Financial Results
- ERYTECH’s key financial figures for the full year of 2017 compared with the same period of the previous year are summarized below:
In thousands of euros | FY 2017 | FY 2016 | ||||||||
Revenues | — | — | ||||||||
Other income | 3,364 | 4,138 | ||||||||
Total operating income | 3,364 | 4,138 | ||||||||
Research and development | (25,463) | (19,720) | ||||||||
General and administrative | (8,791) | (6,808) | ||||||||
Total operating expenses | (34,254) | (26,528) | ||||||||
Total operating loss | (30,889) | (22,390) | ||||||||
Financial income | 539 | 558 | ||||||||
Financial expenses | (3,183) | (70) | ||||||||
Financial income (loss) | (2,644) | 488 | ||||||||
Loss before tax | (33,533) | (21,902) | ||||||||
Income tax | 3 | (10) | ||||||||
Net loss | (33,530) | (21,913) | ||||||||
Net loss for the full year 2017 was €33.5 million, compared to €21.9
million in 2016. The €11.6 million increase was primarily attributable
to the increase in clinical and regulatory development expenses, related
to the company’s ongoing clinical programs in ALL, AML and pancreatic
cancer, the continuation of its regulatory initiatives in
- R&D expenses increased by €5.7 million. The increase included additional expenses in external provider services in relation with the company’s intensified clinical and regulatory activities, as well as the additional staffing for preclinical research and clinical development.
- G&A expenses increased by €2.0 million, as a result of infrastructure developments to sustain the company’s growth.
- Operating income decreased by €0.8 million, reflecting primarily a decrease in research tax credits.
- The €2.6 million financial loss in 2017 was impacted by a €3.0 million currency exchange variation on the company’s cash position denominated in U.S. dollars and consolidated in euros.
-
In
April 2017 , ERYTECH completed a €70.5 million ($82 million ) private placement in which it issued 3,000,000 new ordinary shares. -
In
November 2017 , ERYTECH completed a global offering of its ordinary shares (including in the form of American Depositary Shares or ADSs) inthe United States andEurope , with gross proceeds of approximately €124 million ($144 million ). The offering resulted in the issuance of a total of 5,374,033 new ordinary shares, comprising 4,686,106 ADSs, at an offering price of$23.26 per ADS inthe United States and 687,927 ordinary shares through a concurrent private placement inEurope and other countries outside ofthe United States andCanada at a price of €20.00 per ordinary share. Each ADS represents the right to receive one ordinary share. The underwriters exercised their overallotment option in full to purchase 702,915 additional ADSs and 103,189 additional ordinary shares in the global offering. Upon the consummation of the global offering, ERYTECH’s ADSs began trading on the Nasdaq Global Select Market onNovember 10, 2017 . -
As of
December 31, 2017 , ERYTECH had cash and cash equivalents totaling €185.5 million (approximately$223 million ), compared with €37.6 million onDecember 31, 2016 . The net cash increase of €147.9 million was primarily the result of €177.4 million in net proceeds from the company’s financing activities in April andNovember 2017 . Excluding the financing rounds, total cash utilization in 2017 was €26.4 million, comprised of a €24.7 million net cash utilization in operating activities and €1.7 million in capital expenditures.
Key News Flow and Milestones Expected over Next 12 Months
-
Meeting with the
FDA to discuss next steps in ALL -
Initiation of a pivotal Phase 3 clinical trial in second-line
pancreatic cancer in
Europe andthe United States - Initiation of a Phase 2 proof-of-concept clinical trial in first-line pancreatic cancer
- Initiation of a Phase 2 proof-of-concept clinical trial in TNBC
- Advance U.S. registration-directed activities for ALL
- CHMP feedback on MAA resubmission for GRASPA in R/R ALL
- Initiation of Phase 1 clinical trial with erymethionase
- Updates on preclinical pipeline programs
Full Year Results 2017 Conference Call Details
As a reminder, ERYTECH management will hold a conference call and
webcast on
The call is accessible via the below teleconferencing numbers, followed by the Conference ID#: 7997444#:
USA: +1 8338186807 | United-Kingdom: +44 02031070289 | |||||
Switzerland: +080 0836508 | Germany: +49 06922224728 | |||||
France: +33 0176748988 | Belgium: +32 024003547 | |||||
Sweden: +46 0856619361 | Finland: +358 0972519310 | |||||
Netherlands: +31 0207075547 | Spain: +34 914142503 | |||||
The webcast can be followed live online via the link: https://edge.media-server.com/m6/p/qa7wj9by
An archived replay of the call will be available for 7 days by dialing
(US &
An archive of the webcast will be available on ERYTECH’s website, under the “Investors” section at investors.erytech.com
2018 Financial Calendar:
-
General Assembly Meeting of Shareholders:
Friday, June 22, 2018 at10:00am CET inParis -
Quarterly financial updates:
-
Business Update and Financial Highlights for the 1st quarter of
2018:
May 14, 2018 (after U.S. market close), followed by a conference call and webcast onMay 15, 2018 (2:30pm CET /8:30am ET ) -
Business Update and Financial Highlights for the 2nd quarter and
first-half of 2018:
September 17, 2018 (after U.S. market close), followed by a conference call and webcast onSeptember 18, 2018 (2:30pm CET /8:30am ET ) -
Business Update and Financial Highlights for the 3rd quarter of
2018:
November 12, 2018 (after U.S. market close), followed by a conference call and webcast onNovember 13, 2018 (2:30pm CET /8:30am ET )
-
Business Update and Financial Highlights for the 1st quarter of
2018:
Upcoming Investor Conferences:
-
Cowen Annual
Health Conference ,March 12-14 ,Boston H.C. Wainwright Global Life Sciences Conference ,April 8-10 ,Monaco -
European Smallcap Event,
April 16-17 ,Paris Kempen Healthcare & Life Sciences Conference ,April 18-19 ,Amsterdam -
BioEquity Europe 2018,
May 14-16 ,Ghent -
Gilbert Dupont Annual Healthcare Conference,
May 29 ,Paris Jefferies 2018 Global Healthcare Conference,June 5-8 ,New-York -
Journée Valeurs Moyennes SFAF,
June 12 ,Paris -
European Midcap Event – Spring,
June 27-28 ,Paris
About ERYTECH: www.erytech.com
Founded in Lyon, France in 2004, ERYTECH is a clinical-stage biopharmaceutical company developing innovative therapies for rare forms of cancer and orphan diseases. Leveraging its proprietary ERYCAPS platform, which uses a novel technology to encapsulate therapeutic drug substances inside red blood cells, ERYTECH has developed a pipeline of product candidates targeting markets with high unmet medical needs. ERYTECH’s initial focus is on the development of products that target the altered amino acid metabolism of cancer cells, depriving them of nutrients necessary for their survival.
The Company’s lead product, eryaspase, also known under the trade name GRASPA®, consists of an enzyme, L-asparaginase, encapsulated inside donor-derived red blood cells. L-asparaginase depletes asparagine, a naturally occurring amino acid essential for the survival and proliferation of cancer cells. L-asparaginase has been a standard component of multi-agent chemotherapy for the treatment of pediatric acute lymphoblastic leukemia (ALL), but side effects limit treatment compliance, especially in adults and patients with weak performance status.
Eryaspase demonstrated positive efficacy and safety results in various clinical trials in ALL, including in a Phase 2 study in patients over 55 years of age and in a Phase 2/3 trial in relapsed or refractory ALL patients, as well as in pancreatic cancer, where it achieved positive results in a Phase 2b trial of second-line treatment of patients with metastatic pancreatic cancer. ERYTECH is preparing for the launch of a pivotal Phase 3 clinical trial in second line pancreatic cancer and Phase 2 trials in first line pancreatic cancer and triple-negative breast cancer.
ERYTECH produces eryaspase at its own GMP-approved and operational
manufacturing site in Lyon (
In addition to eryaspase, ERYTECH is developing erymethionase, methionine-γ-lyase encapsulated in red blood cells, to target cancer cells’ amino acid metabolism and induce tumor starvation. ERYTECH is also exploring the use of its ERYCAPS platform for developing cancer immunotherapies (ERYMMUNE) and enzyme replacement therapies (ERYZYME).
ERYTECH is listed on the Nasdaq Global Select Market in the
Forward-looking information
This press release contains forward-looking statements, forecasts and
estimates with respect to the clinical results from and the development
plans of eryaspase, business and regulatory strategy, and anticipated
future performance of ERYTECH and of the market in which it operates.
Certain of these statements, forecasts and estimates can be recognized
by the use of words such as, without limitation, “believes”,
“anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”,
“may”, “will” and “continue” and similar expressions. They include all
matters that are not historical facts. Such statements, forecasts and
estimates are based on various assumptions and assessments of known and
unknown risks, uncertainties and other factors, which were deemed
reasonable when made but may or may not prove to be correct. Actual
events are difficult to predict and may depend upon factors that are
beyond ERYTECH's control. There can be no guarantees with respect to
pipeline product candidates that the candidates will receive the
necessary regulatory approvals or that they will prove to be
commercially successful. Therefore, actual results may turn out to be
materially different from the anticipated future results, performance or
achievements expressed or implied by such statements, forecasts and
estimates. Further description of these risks, uncertainties and other
risks can be found in the Company’s regulatory filings with the French
Autorité des Marchés Financiers, the Company’s
View source version on businesswire.com: http://www.businesswire.com/news/home/20180312006142/en/
Source:
ERYTECH
Naomi Eichenbaum
Director Investor
Relations
+33 4 78 74 44 38
+1 917 312 5151
naomi.eichenbaum@erytech.com
or
The
Ruth Group
Lee Roth
Investor relations
Kirsten
Thomas
Media relations
+1 646 536 7012
lroth@theruthgroup.com
+1
508 280 6592
kthomas@theruthgroup.com
or
NewCap
Julien
Perez
Investor relations
Nicolas Merigeau
Media
relations
+33 1 44 71 98 52
ERYTECH@newcap.eu